Following recent heart health recommendations that are expected to lead to a massive increase in the use of statin-based drugs like Lipitor and Crestor, an increasing number of medical experts are raising concerns about the so-called “statinization” of America.

In an editorial published in the Journal of the American Medical Association (JAMA) on December 2, a Standford doctor warns about the serious risks associated with the widespread use of the cholesterol-fighting drugs that are part of a class of medications known as statins.

The comments come in response to new heart guidelines issued last month by the American Heart Association (AHA) and the American College of Cardiology (ACC), which indicates that statins are the only drugs doctors should prescribe to lower cholesterol and calls for doctors to toss out cholesterol goal numbers, potentially keeping patients on the drugs permanently.

Dr. John P. A Ioannidis, director of the Stanford Prevention Research Center at Stanford University School of Medicine, indicates that the “statinization” of America and the world could “be one of the greatest achievements or one of the worst disasters of medical history.”

Statins are among the best-selling drugs in the United States, including brand name medications like Lipitor, Crestor and Zocor. The medications generate more than $14.5 billion in combined annual sales.

The drugs use the liver to block the body’s creation of cholesterol, which is a key contributor to coronary artery disease. However, a number of studies have linked the drugs to an increased risk of potentially serious injuries, including muscle damage, kidney problems and diabetes.

The new guidelines, issued on November 12, call for doctors to prescribe statins, and no other drugs, to anyone with at least a 7.5% risk of heart attack or stroke within the next 10 years, among others. If the recommendations are followed, most expect the use of Lipitor, Crestor, Zocor and other statin drugs will skyrocket even further.

Ioannidis is not the first expert to call for caution in following the guidelines. The consumer watchdog organization Consumer Reports warned Americans not to rush to get statin prescriptions, and some critics said the risk assessment calculators were flawed and would result in statin overuse.

in the editorial, Ioannidis estimates that the guidelines could lead to statin use by more than 40 million of the 101 million Americans between the ages of 40 and 79 who do not have cardiovascular disease. Projecting those rates worldwide, he estimates that another billion people around the world would be taking statins if the recommendations are followed internationally. Despite the staggering figures, Ioannidis cautioned that the numbers are probably an underestimate.

He warned that not only is the risk predictor model the groups put forward flawed, but that more attention needs to be given to the possible side effects of the drugs as well.

“Information on potential statin harms (myopathy, diabetes, and more) is accumulating and concerning but also less systematically collected and thus carries more uncertainty than the benefits,” he writes. “The exact incidence of harms could markedly affect the optimal risk threshold for treatment.”

Since the recommendations were handed down, some have questioned ties to the pharmaceutical industry among some panelists who designed the new guidelines. Ioannidis points out that eight of the 15 panelists had industry connections and calls for future panels to include non-industry experts, and perhaps even patients. He also calls on testing the guidelines through studies before putting them into practice.

“With expanded target populations and more affordable generic prices, the cumulative global sales of statins may approach $1 trillion by 2020. Lipitor sales alone exceeded $120 billion between 1996 and 2011,” he notes. “Therefore, funding for trials to demonstrate the best predictive model and treatment threshold should be negligible compared with the accumulated profit from statins and the millions of lives and deaths at stake.”

Statin Health Problems

While most health experts agree that statins are effective in fighting cholesterol, there are a number of risks that have been linked to the drugs, including muscle and kidney damage, and an increased risk of diabetes.

All statins carry warnings about the potential risk of serious muscle injury, known as myopathy. The most severe form of the muscle damage is rhabdomyolysis, which may lead to severe kidney damage, kidney failure and death.

More recently, Lipitor, Crestor and other statins have been linked to an increased risk of diabetes, leading the FDA to require new warnings in February 2012 about potential impact the medications may have on blood sugar levels. Studies have suggested that otherwise healthy individuals who begin taking statins to reduce their risk of heart disease, may actually increased their risk of diabetes, which itself increases a risk of cardiovascular disease.

However, a study published in May in the British Medical Journal suggested that certain statins may carry an increased diabetes risk, Lipitor users facing a 22% increased risk of a diabetes, those taking Crestor were at an 18% increased risk, and patients given Zocor faced a 10% increased risk. The study did not establish a causal relationship between statins and diabetes risk, however.

Crestor (rosuvastatin) was approved by the FDA in 2003 and is manufactured by AstraZeneca. It is currently the best-selling statin in the country with $5.4 billion in sales over the last 12 months. It is also the most widely-prescribed drug in the nation.

Lipitor (atorvastatin) was previously the best-selling statin, generating more than $125 billion in sales for Pfizer before it became available as a generic in 2011.

Pfizer faces a growing number of Lipitor diabetes lawsuits by plaintiffs who say that the company failed to warn about the potential risks associated with using the medication. The company has been hit with more than 100 claims in U.S. District Courts nationwide, and it is ultimately expected that there may be thousands of claims filed by otherwise healthy women who were prescribed the statin as a preventative measure for heart disease.